Tissue capturing and suturing device and method

ABSTRACT

A combination tissue apposition and suture capturing device ( 100 ) for performing endoscopic procedures typically in the gastro-esophageal tract. The device ( 100 ) is particularly adapted for forming multiple plications used in a gastroplasty procedure devised to cure or ameliorate gastro-esophageal reflux disease. The device include a tissue sewing capsule ( 102 ) attached to the distal end of an endoscope having a needle ( 120 ) that is deposited in a capsule ( 102 ) distal tip cavity following the suturing of a tissue fold and retrieved to enable the suturing of a subsequent tissue fold without the need for multiple intubations. A suture clip delivery device ( 200 ) is also disclosed that is adapted to fit within the capsule to enable suture capture without the need for multiple intubations. The combination device eliminates the need for an overtube and maximizes the speed efficiency of the gastroplasty procedure. A method for using the combination device is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/803,956, filed May 16, 2007, which is a continuation of U.S. patentapplication Ser. No. 10/275,534, filed Nov. 6, 2002, which is the U.S.National Stage of International Application No. PCT/US01/16025, filedMay 19, 2001, which claims the benefit to U.S. Provisional ApplicationsNos. 60/205,741, filed May 19, 2000, 60/205,444, filed May 19, 2000, and60/253,970, filed Nov. 29, 2000, and International Application No.PCT/US01/07349, filed Mar. 5, 2001, the entire contents of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a novel combination of endoscopictissue apposition devices and suture clip delivery devices.Specifically, the invention provides an endoscopic apposition deviceconfigured to collect and secure a plurality of tissue portions with asingle intubation of the device. The invention is applicable to bothflexible and rigid endoscopy.

BACKGROUND OF THE INVENTION

Endoscopic apposition devices are devices that can be used in the bodyof a patient without the need to make an external incision in thepatient, the device being controlled externally of the patient byendoscopic means. Apposition devices may comprise a sewing or staplingdevice for use in flexible endoscopy, though it is also applicable todevices for use in rigid endoscopy.

Endoscopic tissue apposition devices are useful to help perform agastroplasty procedure to correct a condition known as gastro-esophagealreflux disease (GERD). This condition, believed to afflict as many as15,000,000 individuals in the United States alone, results from theinability of the sphincter muscle (known as the lower esophageal orcardiac sphincter), at the junction between the stomach and theesophagus to function properly. Such malfunction enables reflux ofstomach acid into the esophagus. The object of the gastroplastyprocedure is to stitch together portions of stomach tissue intoplications in a region proximal to the malfunctioning sphincter toreduce the cross-sectional area of the gastro-esophageal juncture andmimic the valve-like function of the sphincter.

To perform the procedure, an apposition device, such as a sewing capsuleis attached to the end of a viewing endoscope and is inserted through apatient's esophagus to form a plurality of stitches in stomach tissueslightly below the sphincter. The sewing capsule has an aspiration portfor generating negative pressure to suction stomach wall tissue into thesewing capsule. A first stitch is made through the stomach tissue to oneside of the esophagus, and a second stitch is made, with the same suturethread, in stomach tissue adjacent to the first stitch. The two stitchesthen are drawn together to pull together the diametrically opposed,stitched stomach portions. In a preferred procedure, a tubularconfiguration having a somewhat figure-eight cross-sectionalconfiguration is formed.

In accordance with what has been, until now, the conventional procedurefollowed, after the sutures are applied, the endoscope is removed fromthe patient and a knot is tied with the free ends of the suture threadthat extend outside of the patient to maintain the figure-eightconfiguration. The knot is pushed down to the site of the sutures by athread guide device that has been positioned at the distal end of theendoscope. To help navigate the knot to a location where it willeffectively hold the tissue, the knot is viewed through the viewingchannel of the endoscope as it is guided to the stomach. To be visiblethrough the endoscope, the knot must be maintained in front of theviewing channel port at the distal face of the endoscope whilepositioning the thread guide device so as not to block the viewingchannel.

The suturing and knotting procedure is repeated several times atlongitudinally spaced intervals to create a plurality of figure-eightconfigurations extending longitudinally of the esophagus into thestomach. Suturing the stomach tissue in this manner essentiallylengthens the esophageal passage and defines a structure having avalving action that is proven effective to prevent gastro-esophagealreflux. After a sufficient number of knots and sutures have been placed,a thread cutter, also operable through the endoscope, may be employed tocut the suture thread at points that are close to the tissue.

Endoscopic sewing devices are described in, for example, U.S. Pat. Nos.5,080,663 and 5,792,153. Those patents disclose a sewing device forpassing a thread through a tissue portion, which comprises a hollowneedle movable between a first position in which it is out of the saidtissue portion and a second position in which it passes through the saidtissue portion, and a thread carrier adapted to be attached to thethread and being receivable within the hollow needle. The sewing devicecomprises a body, which defines a cavity within which the tissue portioncan be held by means of suction, and the hollow needle is mounted formovement in the body between the first and second positions.

U.S. Pat. No. 5,792,153 discloses two suturing device embodiments: asingle stitch sewing device and a multiple stitch sewing device. In thesingle stitch device, a thread carrier is transported by the needlethrough the tissue as the latter passes from its first position to itssecond position. When the needle returns to its first position, thethread carrier is left behind in the distal end of the sewing capsule.In the multiple stitch device, the same procedure occurs, but it isfollowed by a further step in which the hollow needle travels from itsfirst position to its second position, picks up the thread carrier, andreturns it. A second stitch may be formed during the next step. Thewhole sequence of steps is repeated as many times as may be required toform the desired number of stitches.

Similar advancements have been made with respect to the suture securingstep that follows the stitching step. One such improvement is disclosedin U.S. Pat. No. 5,584,861 to Swain. The Swain patent discloses a sutureclip and suture clip delivery device that is used in place of half hitchknots. The disclosed suture clip is a cylinder with a plug that can bereleasably secured in the cylinder. The disclosed suture clip deliverydevice includes a tube, the distal end of which has a recess forreceiving the suture clip. An axially movable stirrup is provided at thedistal end that has the capacity to be moved from a first position thatsecures the suture clip to the tube and a second position that allowsfor the suture clip to be removed from the recess.

An aperture is provided in the cylinder to receive the suture. Thecylinder is advanced over the suture that exits from a proximal end ofthe cylinder and enters the tube. An aperture in a sidewall of the tubeprovides egress for the suture. The plug is then advanced down the tubeand into the cylinder. The interfacing walls of the cylinder and plugcapture the suture. A pusher is used to force the plug into the cylinderwhile the stirrup maintains the suture clip in the recess. Followingplug insertion, the stirrup, which is offset from the center axis of thetube, is advanced distally from the distal end of the tube to releasethe suture clip from the tube.

With all the improvements provided by the sewing capsules and suturesecuring devices, significant problems persist with the describedgastroplasty procedure. One of the significant problems is the time andnumber of intubations needed to perform the various procedural stepsendoscopically. Due to a number of concerns, a patient is typicallyanesthetized for no more than approximately 40 minutes. In this periodof time, procedures such as the gastroplasty procedure must be performedto completion.

Minimizing the number of intubations and reducing the procedure timeduring which the patient must be kept under conscious sedation aresignificant considerations in any endoscopic procedure. In thegastroplasty procedure, several intubations have to be performed tocreate several plications. The prior art suturing devices must bewithdrawn from the patient for each successive stitch made withsingle-stitch embodiments and must otherwise be repositioned for eachstitch made with multi-stitch embodiments. The same is true of thesuture securing devices. The devices must be withdrawn and repositionedbetween successive suture securing steps. The use of such devices isinvariably long and cumbersome. There is a need to provide an endoscopictissue apposition device and suture securing device that minimizesprocedure time and the number of intubations while still joining thesame number of tissue plications together during the procedure.

To reduce the trauma experienced by a patient having multiple devicesintubated numerous times for one gastroplasty procedure, an overtube isplaced in the gastro-esophageal tract. Although an overtube provides abarrier between the devices used to perform the procedure and theluminal walls of the tract, the act of inserting the relatively largediameter tube into the tract and the presence of the tube in the tractare perhaps the most significant sources of patient discomfort. There isa need to eliminate the requirement for an overtube to perform thedescribed gastroplasty procedure. The invention disclosed hereinprovides such an improvement.

It is among the general objects of the invention to provide a tissueapposition device and suture securing device that, in combination,eliminate the need to use an overtube when performing a gastroplastyprocedure. A further object is to provide a tissue apposition devicethat is adapted to receive a secure securing device to eliminate theneed for multiple intubations to secure a plurality of tissue plicationsrequired to attach or repair internal tissue by a tissue securementmechanism comprising suture or staples. It is another object of theinvention to provide an endoscopic apposition device that is simple andeconomical to fabricate by injection molding techniques. It is anotherobject of the invention to provide a tissue apposition device havinglongitudinal flexibility to be easily navigable through a natural bodylumen while mounted at the distal end of an endoscope. It is anotherobject of the invention to provide a simplified tissue suture meanshaving an anchor at one end which can remain on the through side oftissue during the process of tissue securement. These and other objectsof the invention will become apparent from a reading of the followingsections.

It is to be appreciated that the combination tissue apposition andsuture securing device disclosed herein has a potentially wide range ofapplications including, but not limited to, the attachment of devices,e.g., a pH monitor to the gastrointestinal wall, the closure ofperforations or ulcers, the creation of anastomoses, plication formationto address severe obesity and polyp plications. The device can be usedwith an endoscope, can be formed as the terminus of a catheter incombination with a visualization device such as an fiberoptic eye wireas is known in the art.

SUMMARY OF THE INVENTION

The present invention pertains to improvements to endoscopic appositiondevice and suture clip delivery devices. The improvements may beembodied in a tissue apposition device similar to those disclosed inU.S. Pat. No. 5,792,153 or 5,080,663, or a stapling device such as isdisclosed in U.S. Pat. No. 5,037,021. The disclosures of the abovelisted patents are incorporated by reference herein, in their entirety.The prior art endoscopic tissue apposition devices provided a mechanismfor capturing only a single fold with one intubation. The presentinvention provides a tissue apposition device capable of capturingmultiple tissue folds and securing the sutures used to capture the foldswith one intubation. The elimination of the need for multipleintubations eliminates the need for an overtube with respect toendoscopic procedures performed in the gastro-esophageal tract.

The device is comprised of a generally cylindrically shaped capsuleattachable to the distal end of an endoscope, preferably a flexibleviewing endoscope. The capsule comprises, in one embodiment, a bodyhaving an arc shaped suction port into which can be captured portions oftissue. The suction port defines an opening to a vacuum chamber. Thevacuum chamber is operated through a vacuum source line that can extendinteriorly or exteriorly to the endoscope.

Application of vacuum pressure causes tissue to be suctioned into thesuction port and into the vacuum where a needle assembly comprising aneedle releasably locked to a pusher via mating surfaces and an outerlocking sleeve is adapted to carry a suture in a distal axial directionthrough into and through the tissue and into a distal tip of thecapsule. Formed in the distal tip of the capsule is a cavity adapted toreceive the needle assembly. A pair of springs are oriented parallel inthe cavity for receiving the needle assembly. Distal faces of thesprings engage a proximal edge of the needle and provide a restrainingforce to retraction of the needle. The locking sleeve is proximallyretracted which allows the pusher to disengage from the needle thatremains restrained by the springs. The pusher is retracted to allow forthe release of the sutured tissue fold.

Following release of the tissue fold, the pusher is re-advanced into thedistal tip of the capsule. The locking sleeve is also advanced to lockthe needle onto the pusher. Proximal retraction of the pusher in alocked condition with the needle overcomes the restraining force of thesprings that flex radially outwardly to allow the needle to be retractedinto the proximal end of the capsule. The needle assembly is now in acondition to implant a suture in a second tissue fold. The process canbe continually repeated for virtually any selected number of tissuefolds, all of which will be connected by a single suture, all with asingle intubation.

The tissue apposition device of the present invention offers anotheradvantage over previous designs in that the entire capsule body may beinjection molded from a polymer material. A single piece injectionmolded unit is easier to produce than previous capsule designs, whichwere machined from metal and comprise several assembled components.

In another aspect of the invention, the tissue apposition capsule bodyis adapted to utilize and receive a novel tissue suturing device. Onetissue securement mechanism embodiment comprises sutures havinganchoring elements at one end that permit them to be passed throughtissue and then become anchored behind the tissue layer to permitsuturing and retention of the fold of tissue. The anchoring element ofthe special suture material, such as polypropylene, may comprise acylindrical tube with detents formed in a sidewall of the tube. A needlehaving a longitudinal slot and a channel is adapted to receive theanchor or tag and deposit it in the distal tip of the capsule. In thisembodiment, the needle is retrieved with the pusher and the tag isretained in the capsule distal tip by virtue of the interaction of thedetents with the springs. To allow release of the tag from the needle,the locking sleeve is only partially retracted to allow the distal endof the needle to expand radially outwardly while the proximal end isradially restrained to maintain engagement with the pusher. Followingrelease of the sutured tissue fold, the needle/pusher assembly isreintroduced into the distal tip and the locking sleeve fully advancedto retrieve the tag. In an alternate embodiment, the tag is releasedwith the sutured tissue fold and the needle is retracted out of theendoscope for the loading of another anchor for insertion into anothertissue fold.

Also described herein is a suture clip delivery device adapted fornavigation through the working channel of an endoscope and through thecapsule channel adapted to receive the needle assembly. The deliverydevice comprises a multi-coaxial catheter with a three or four fingercollet jaw affixed at a distal end. The catheter has a distal end fromwhich the collect fingers distally project. The collet fingers are madeof a material such as stainless steel or an engineering grade of plasticthat allow the collet fingers to flex or spring from a pre-biased firstopen position to a second closed position and back to the firstposition. Alternatively, the collet fingers can be designed to flex orspring from a pre-biased first closed position to a second open positionand back to the first position. The collet fingers define a cage withinwhich a suture clip assembly is premounted. The cage is definedproximally by a distal end of the collet body and distally by flangesextending radially inwardly from the distal ends of the collet fingers.In one embodiment, the case is sized so that a plurality of suture clipplugs can be preloaded into the cage along with a single suture clipring. By biasing the collet fingers in an open position, the need forcam surfaces and cam followers is eliminated.

In one embodiment, a separate control surface provided coaxially aboutthe collet cage is employed to slide the outer sliding sleeve relativeto the collet cage and the pusher. With any of the embodiments, theouter sliding sleeve is provided to secure the collet fingers in aclosed position when placed in a distally advanced position. The outersliding sleeve performs the additional function of severing the sutureat a point proximal to the suture clip after engagement of the sutureupon proximal retraction. One or more suture slots are provided in thedistal end of the outer sliding sleeve to provide suture exits. A distalend of the suture slots can be sharpened to sever the suture. Uponproximal retraction of the outer sliding sleeve, the distal end ofsuture slot engages the suture and severs it when the distal end of thesuture slot travels proximally to a cutting edge formed at or near theproximal end of the collet fingers. The design of the delivery deviceenables the suture clip to be cinched in close proximity to the suturedtissue as well as allow for the severing of the suture tails and releaseof the suture from the delivery device in one step.

The suture clips adapted for use with the suture clip delivery deviceare comprised of a plug and a ring that are configured to allow a sutureto inter-wind through the clip in such a manner that the clips move withminimal friction while in an open position. The plug is a headlessdesign that reduces abrasion of the suture as it exists the suture clipends. In a closed position, the clip captures the suture by frictionalengagement. The ring and plug components of the clip can be providedwith interlocking features for enhancing the suture capturing effect.

Once threaded into the ring and plug, the suture is passed throughfinger slots formed between adjacent collet fingers and out the sutureslot of the outer sliding sleeve. This enables the suture tails to bechanneled externally of the catheter for removal at the proximal end ofthe catheter outside the patient after the tails have been severed at apoint proximal to the now assembled suture clip. The catheter operatormay thread a suture through a clip and then load the clip into thetooling or thread the suture through a premounted clip. Afterpositioning the delivery system at the sutured tissue site, the deviceoperator activates the handle to apply a distally directed force to theclip, thereby locking it to the suture. The application of force securesthe clip components thus capturing the suture material within the matingsurfaces. A second, proximally directed force is applied to the slidingsleeve to release radial restraint on the collet fingers that allows thesecured suture clip to be deployed and to sever the suture tails inclose proximity to the suture clip.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following further description thereof,with reference to the accompanying drawings wherein:

FIG. 1 is a perspective view of a suture capsule with a locking handleremoved according to one embodiment of the invention.

FIG. 2 is a perspective view of a needle assembly adapted for use in asuture capsule according to one embodiment of the invention.

FIG. 3 is a partial sectional view of a capsule/locking sleeve/needleassembly according to one embodiment of the invention.

FIG. 4 is a partial sectional view of a capsule/needle assemblyaccording to one embodiment of the invention.

FIG. 5 is a partial sectional view of a capsule/locking sleeve/needleassembly according to another embodiment of the invention.

FIG. 6 is a partial sectional view of a needle assembly with a suturesecured to the needle disengaged from a pusher in a distal end of asuture capsule according to one embodiment of the invention.

FIG. 7 is a partial sectional view of a suture capsule vacuum chamberand distal cavity with a needle assembly lodged in the distal cavityaccording to one embodiment of the invention.

FIG. 8 is a partial sectional view of a needle assembly with a retractedlocking sleeve according to one embodiment of the invention.

FIG. 9 is a top perspective view of the distal end of a needle assemblywith a retracted locking sleeve according to one embodiment of theinvention.

FIG. 10A is a partial side elevational view of a suturecapsule/endoscope assembly with tissue suctioned into the suctionport/vacuum chamber according to one embodiment of the invention.

FIG. 10B is a partial side elevational view of a suturecapsule/endoscope assembly with tissue suctioned into the suctionport/vacuum chamber with a suture/tag assembly piercing the tissueaccording to one embodiment of the invention.

FIG. 10C is a partial side elevational view of a suturecapsule/endoscope assembly with a released first tissue mound withembedded suture and distal anchor tag and a second tissue moundsuctioned into the suction port/vacuum chamber with a suture/tagassembly piercing the second tissue mound according to one embodiment ofthe invention.

FIG. 10D is a partial side elevational view of a suturecapsule/endoscope assembly with released first and second tissue moundswith a single suture embedded in each tissue mound with separate distalanchor tags.

FIG. 11 is a side elevational view of a tissue plication with a suturepiercing the plication mound halves and secured with a suture clip.

FIG. 12 is a schematic view of a suture capsule/endoscope assemblyaccording to one embodiment of the invention.

FIG. 13 is a tissue plication secured with a suture clip according toone embodiment of the invention.

FIG. 14 is a tissue plication secured with a suture clip according toanother embodiment of the invention.

FIG. 15A is a top view of a needle/pusher assembly according to oneembodiment of the invention.

FIG. 15B is a side elevational view of the needle/pusher assembly shownin FIG. 15A.

FIG. 16 is a sectional view of the needle/pusher assembly shown in FIGS.15A and 15B.

FIG. 17 is a perspective view of a needle assembly according to oneembodiment of the invention.

FIG. 18A is a side elevational view of a suture capsule/endoscopeassembly with tissue suctioned into the suction port and vacuum chamberaccording to one embodiment of the invention.

FIG. 18B is a side elevational view of a suture capsule/endoscopeassembly with tissue suctioned into a suction port and vacuum chamberand with a needle assembly advanced to a proximal end of the tissueaccording to one embodiment of the invention.

FIG. 18C is a side elevational view of a suture capsule/endoscopeassembly with a needle/suture/tag assembly advanced distally through thetissue according to one embodiment of the invention.

FIG. 18D is a side elevational view of a suture capsule/endoscopeassembly with a partially retracted needle and a suture tag assemblyreleasably locked into a distal end of the suture capsule according toone embodiment of the invention.

FIG. 18E is a side elevational view of a suture capsule/endoscopeassembly with a fully retracted needle and a released tissue moundpierced by a suture.

FIG. 18F is a side elevational view of a suture capsule/endoscopeassembly with a released tissue mound pierced by a suture and a distallyadvanced needle encompassing a suture anchoring tag according to oneembodiment of the invention.

FIG. 18G is a side elevational view of a suture capsule/endoscopeassembly with a released tissue mound and a retracted needle/tagassembly according to one embodiment of the invention.

FIG. 18H is a side elevational view of a suture capsule/endoscopeassembly with a released tissue mound pierced by a suture and a secondtissue mound suctioned into a suction port and vacuum chamber with aneedle/tag assembly partially piercing the second mound according to oneembodiment of the invention.

FIG. 18I is a side elevational view of a suture capsule/endoscopeassembly with two released tissue mounds pierced by a suture with aneedle/tag assembly in a retracted position according to one embodimentof the invention.

FIG. 18J is a side elevational view of a suture capsule/endoscopeassembly with two released tissue mounds pierced by a suture with asuture clip delivery device partially advanced in the suture capsuleaccording to one embodiment of the invention.

FIG. 18K is a side elevational view of a suture capsule/endoscopeassembly with two released tissue mounds pierced by a suture with asuture clip delivery device fully advanced in the suture capsule in apre-cinched state according to one embodiment of the invention.

FIG. 18L is a side elevational view of a suture capsule/endoscopeassembly with two released tissue mounds pierced by a suture and cinchedwith a suture clip secured to the suture and being deployed by a sutureclip delivery device according to one embodiment of the invention.

FIG. 18M is a side elevational view of a suture capsule/endoscopeassembly with a cinched plication and a partially retracted suture clipdelivery device according to one embodiment of the invention.

FIG. 18N is a side elevational view of a suture capsule/endoscopeassembly with a tag retention detent in the capsule distal end accordingto one embodiment of the invention.

FIG. 18O is a side elevational view of a suture capsule/endoscopeassembly without a tag retention detent in the capsule distal endaccording to one embodiment of the invention.

FIG. 19 is a somewhat diagrammatic view of a suture capsule according toone embodiment of the invention.

FIG. 20 is a partial sectional somewhat diagrammatic view of a suturecapsule suction port and distal end according to one embodiment of theinvention.

FIG. 21 is a side perspective view of a suture clip delivery devicedistal collet cage with a suture threaded through the collet cageaccording to one embodiment of the invention.

FIG. 22 is a top plan view of a suture capsule with a suture clipdelivery device advanced through the capsule.

FIG. 23 is a side partial sectional view of a suture clip deliverydevice collet cage with a disassembled suture clip plug and ring and asuture threaded through the delivery device according to one embodimentof the invention.

FIG. 24 is a side partial sectional view of a suture clip deliverydevice with a cinched suture clip according to one embodiment of theinvention.

FIG. 25 is a side partial sectional view of a suture clip deliverydevice with a cinched suture clip and a severed suture according to oneembodiment of the invention.

FIG. 26 is a side view of a suture clip delivery device including colletcage and handle assembly with a suture threaded through the collet cageand a sliding cutter handle in a distal position according to oneembodiment of the invention.

FIG. 27 is a side view of a suture clip delivery device including colletcage and handle assembly with a suture threaded through the collet cageand severed and with a sliding clutter handle in a retracted position.

FIGS. 28A-30 show successive steps in the operation of a prior artsingle stitch sewing device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

A description of the embodiments of the present invention is bestpresented in conjunction with an explanation of the operation of a priorart tissue apposition device, which this invention serves to improve.FIGS. 28A-30 depict a prior art endoscopic suturing device disclosed inU.S. Pat. No. 5,792,153. FIG. 28A shows the distal end of a flexibleendoscope 90, on which a sewing device 2 is attached. The endoscope isprovided with a viewing channel, which is not shown, but whichterminates at a lens on the distal face of the endoscope. The endoscopeis further provided with a biopsy or working channel 3, and a suctionchannel 4 the proximal end of which is connected to a source of vacuum(not shown). The suction channel 4 may comprise a separate tube thatruns along the exterior of the endoscope, rather than an internal lumenas shown. The sewing device 2 has a tube 5, which communicates with thesuction pipe 4 and has a plurality of perforations 6 therein. Theseperforations communicate with an upwardly open vacuum chamber 7 formedin the sewing device.

A hollow needle 8 is mounted in the biopsy channel 3, with its beveledtip extending into the sewing device. The needle has a channel 9extending therethrough. A flexible, wire-wound cable 10 has its forwardend attached to the rear of the needle 8, and a center wire 11 runswithin the cable 10, along the entire length thereof, and islongitudinally movable with respect thereto. The diameter of the wire 11is such that it is longitudinally movable within the channel 9 and, inthe position shown in FIG. 28A, the forward end portion of the wire 11extends into the rear end portion of the channel 9. A thread carrier inthe form of a tag 12 is slidably and releasably mounted in the channel9. The tag is shown in detail in FIG. 28B. The tag is hollow and has anaperture 13 extending through the sidewall thereof. As can also be seenin FIG. 1, one end of a thread 14 is secured to the tag by passing itthrough the aperture 13 and tying in the end of a knot 15 of sufficientsize to prevent the thread escaping from the tag. The tag may be madefrom a relatively rigid material such as stainless steel.

At the distal end of the sewing device is defined a hollow head portion16 defining a chamber 20 therein. Between the chamber 20 and the cavity7 is a wall 17, in which an aperture 18 is formed. The aperture 18 has adiameter that is marginally greater than the external diameter of theneedle 8, and is aligned therewith. The clearance between the needle 8and the aperture 18 must be sufficiently small to prevent tissue beingforced through the aperture and causing the needle to jam. Finally, FIG.28A shows a portion of the patient's tissue 19, in which a stitch is tobe formed.

In operation, suction is applied to the suction pipe 4, and thence, viathe perforations 6 in the tube 5 to the cavity 7. This sucks into thecavity a U-shaped portion 19 a of the tissue 19, as shown in FIG. 29.The hollow needle 8 is pushed through the U-shaped tissue portion 19 aby extending distally the wire-wound cable 10 and associated needle 8.After full advancement of the needle through both folds of the U-shapedtissue portion, the tip potion of the needle 8 is distal to the wall 17and within the chamber 20 in the hollow head portion 16. Distal movementof wire 11, slidably received within the wound cable 10, pushes the tag12 out of the channel 9 and into the chamber 20 where it rotates out ofalignment with aperture 18 to become captured in the chamber.

The wire 11 is then withdrawn proximally, followed by proximalwithdrawal of the cable 10, to withdraw the needle 8 from the tissueportion 19 a. The suction is then discontinued allowing the U-shapedtissue portion 19 a to be released from the cavity 7. As shown in FIG.30, the released tissue is left with a suture thread 14 passing throughthe two layers of tissue that form the U-shaped fold 19 a. One end ofthe suture is joined to the tag 12 that remains captured in the chamber20 and the other end of the suture extends through the patient'sesophagus and out of the mouth. Finally, the endoscope and dewing deviceare withdrawn from the patient. In so doing, the thread 14 is pulledpartially through the tissue portion 19 a, as the captured tag 12 iswithdrawn proximally and brought outside the patient.

With both ends of the thread 14 outside of the patient, the thread canbe knotted and the knot endoscopically pushed down to the suture siteand severed by an endoscopic knot pusher such as that disclosed in U.S.Pat. No. 6,010,515 (Swain et al). As an alternative to tying a knot, asuture lock or clip may be guided over the suture thread, down theesophagus and secured via an endoscope or suitable delivery catheter tohold the suture thread tight against the tissue. Examples of suitablesuture locks and delivery systems are disclosed in PCT ApplicationPCT/US01/filed Mar. 5, 2001, the contents of which are incorporatedherein by reference. In using the endoscopic suturing device to treatG.E.R.D. it is believed that capture of multiple tissue portions andsuturing and gathering them together provide an effective treatment. Toaccomplish this using the prior art device, multiple intubations of theendoscope down the patient's esophagus are required. Once, multiple(tissue portions, have been captured and sutured with thread, they aregathered together and secured by tying of surgical knots in the threador application of suture lock devices. Each step in the process requiresseparate intubations which prompts the need for an overtube, which isknown to cause significant patient discomfort. It is an object of thepresent invention to enable the capturing, suturing and securing ofmultiple tissue portions into multiple plications with one intubationand without the need for an overtube.

Referring to FIGS. 1, 19 and 20, a multi-functional sewing devicedesignated generally as 100 is shown separate from an endoscope. Thesewing device comprises a generally cylindrical capsule 102 madeillustratively from a machined biocompatible metal such as stainlesssteel or from an injected molded engineering grade of plastic orpolymer. Capsule 102 has a modular or integral distal tip 104 that ispreferably hemispherical in configuration to enhance ease of advancementthrough luminal channels or cavities of a mammalian body and to minimizetrauma and irritation to the contacted tissue surfaces. Distal tip 104has portions defining a distal chamber (not shown) that is used toreceive a needle or suture tag as described below. Proximal to thedistal tip is a suction port 106 adapted to receive tissue suctionedinto the port with vacuum pressure. Suction port 106 is preferablyformed as an oval or circle to eliminate edges that could irritatesuctioned tissue. Suction port 106 opens into a vacuum chamber 108formed in the body of capsule 102 that is adapted to receive suctionedtissue in preparation for suturing.

A locking sleeve 110 (shown in suction port 106) extends through achannel (not shown) in the proximal end of capsule 102. A rigidattachment tube 112 integral to capsule 102 extends proximally from aproximal end of capsule 102 and is dimensioned to fit snugly within theworking channel of an endoscope. Tube 112 provides leverage for securingcapsule 102 to the distal end of an endoscope along with an attachmentramp 114 that uses a wedge (not shown) to frictionally engage and lockto the endoscope. A lumen of tube 112 is contiguous with the capsulechannel through which locking sleeve 110 extends. Formed on a topsurface of locking sleeve 110 is a flat surface 116 adapted to receive asuture 118. Surface 116 provides an essentially low frictionabrasion-free passage for suture 118 proximal to its insertion into aneedle 126 shown in FIG. 2. Surface 116 extends proximal to but not intoa distal end of locking sleeve 110 to maintain concentricity and radialstrength of the distal end.

A pusher 120 is provided to advance and retract needle 126. Pusher 120is concentric to locking sleeve 110 and is dimensioned to extend throughand slide freely within locking sleeve 110 as well as through and outthe proximal end of the endoscope working channel to which capsule 102is attached. Attached to a proximal end of pusher 120 is pusher handle122 configured to provide a surface to apply hand pressure with the palmof a hand to advance needle 126 and a finger gripping surface on adistal side to retract needle 126.

Shown in FIGS. 2, 8 and 9 is a needle assembly designated generally as124 that is comprised of the locking sleeve 110 and a slotted hypodermicneedle 126 with a preferred beveled distal tip 128. Needle 126 can bemade from any suitable biocompatible metal such as stainless steel orpolymeric compound such as PEEK (polyetheretherketone), commerciallyavailable from Victrex. The compound is a linear aromaticsemi-crystalline polymer. A needle suture slot 130 is formed preferablyin a central portion of needle 126 to receive in locking engagementsuture 118. Any number of methods can be used to secure suture 118 toneedle 126 including crimping, staking, thermo bonding or melting (forneedles made from polymeric materials), and knotting. FIGS. 3-8 show asuture locking plug 144 securing suture 118 to needle 126.

Shown in FIGS. 3-7 is needle 126 releasably locked to pusher 120 throughthe interaction of mating surfaces formed on the two components. Needle126 has an inwardly directed annular ring 132 projecting from an innerwall of needle 126. Pusher 120 has an annular channel 134 dimensioned toconform to the shape of annular ring 132. Pusher 120 has across-sectional diameter that is dimensioned to fit within the innerdiameter of needle 126. A distal tip of pusher 120 is preferablyhemispherical in configuration to facilitate registration of pusher 120in the proximal end of needle 126. Forward advancement of pusher 120causes annular channel 134 to engage annular ring 132. Subsequentforward advancement of locking sleeve 110 secures the engagement ofchannel 134 to ring 132. In an alternative embodiment, the proximalportion of ring 132 is removed (not shown) so that the proximal end ofneedle 126 has a reduced neck configuration. This configuration easesthe release of pusher 120 when retracted out of distal tip 104subsequent to the retraction of locking sleeve 110.

Slots 127 formed in the annular wall of needle 120 extend from theproximal end toward the distal end, a fraction of the longitudinallength of needle 126. The slots are preferably diametrically opposed180° and allow for the proximal end of needle 126 to flex radiallyoutwardly. One or more slots can be used; two are preferred. Therelative flexibility of the proximal end of needle 126 allows theportion of pusher 120 distal to channel 134 to traverse ring 132 duringdistal advancement. A sleeve channel 136 formed in the distal end ofcapsule 102, and concentric with the channel receiving needle 126, isdimensioned to receive in sliding engagement, locking sleeve 110. Adistal end 138 of sleeve channel 136 is preferably beveled to the samedegree as the distal end 139 of locking sleeve 110. Distal end 138 actsas a stop to prevent needle 126 from being advanced into the innersurface of distal tip 104. A shoulder 140 is formed on the inner surfaceof locking sleeve 110 for contacting a proximal edge 123 of needle 126to maintain the concentricity of needle 126 when being urged distally incapsule 102.

Provided in distal tip 102 are detent springs 142, the distal edges ofwhich contact the proximal edge 121 of needle 120. Springs 142 arepreferably substantially parallel and oriented perpendicular to thecapsule longitudinal axis. The ends of the springs 142 are secured tothe inner wall of distal tip 102 by either sitting in annulardepressions formed on the inner wall or by mechanical fasteners. Springs142 are adapted to provide a mechanical stop that prevents needle 126from being retracted out of distal tip 104 when pusher 120 is retracted.To perform this retention function, any spring can be used that canapply a radial force to needle. Among the possible variants are flat,round and helical springs. The importance of this function is explainedbelow.

To operate this embodiment of the invention, sewing device 100 isback-loaded into the working channel of an endoscope 90 and secured toits distal end as shown in FIGS. 12, 18N and 18O. A suture 118 issecured to needle 124 after being threaded through the working channelof the endoscope and over flat surface 116 of locking sleeve 110. Theendoscope/sewing device assembly is advanced through a body lumen to aselected site, preferably within the stomach below the lower esophagealor cardiac sphincter. Once in place, vacuum pressure is commenced invacuum chamber 108 from a source external to the endoscope to suctiontissue from the body lumen into suction port 106. Needle 126 withattached suture 118 is advanced distally through the tissue and intodistal tip 104 of capsule 102. Distal advancement of needle 126 isaccomplished by providing a distally directed force to pusher handle 122that causes distal translation of pusher 120 and needle 126. Preferably,a locking sleeve handle (not shown), attached to the proximal end oflocking sleeve 110 and located distal to pusher handle 122, projectsproximally from the proximal end of the endoscope, and is advancedsimultaneously with pusher handle 122 to ensure a positive lock betweenneedle 126 and pusher 120. Locking sleeve 110 can be maintained in adistally extended position by maintaining manual pressure on the lockingsleeve handle or via springs as described in PCT Application No.PCT/US01/07349.

Distal advancement of the pusher/locking sleeve/needle assembly iscontinued until distal end 139 of locking sleeve 110 contacts distal end138 of locking channel 136. The distal travel of needle 126 into distaltip 104 results in the proximal end of needle 126 advancing distallypast a distal edge 143 of springs 142 as illustrated in FIG. 6. Withsuture 118 advanced completely through the captured tissue, lockingsleeve 110 is proximally retracted to allow for the disengagement ofpusher 120 from needle 126 (FIG. 4). Preferably, locking sleeve 110 isretracted until distal end 139 is proximal to vacuum chamber 108.

Proximal retraction of pusher 120 while still engaged to needle 126causes proximal edge 121 to register with distal edge 143 of spring 142thereby restraining needle 126 in distal tip 104. Further retraction ofpusher 120 coupled with the restraining force provided by spring 142causes the proximal end of needle 126 to flex radially outwardly therebydisengaging the mating surfaces of ring 132 and channel 134. Needle 126is cradled in distal tip 104 by the cylindrical opening formed in distaltip 104. To allow for the release of the captured tissue, pusher 120 isretracted proximal to vacuum chamber 108. Following retraction oflocking sleeve 110 and pusher 120, the vacuum pressure is terminatedwhich releases the captured tissue.

To prepare sewing device 100 to capture and suture another fold oftissue, pusher 120 is re-advanced through vacuum chamber 108, throughsprings 142 which expand radially outwardly and into the proximal end ofneedle 126. Locking sleeve 110 is advanced either simultaneously orslightly behind pusher 120 to lock the engagement of ring 132 andchannel 134. With locking sleeve 110 maintained over pusher 120 andneedle 126, pusher handle 122 and handle for locking sleeve 110 areproximally retracted as a unit to retract needle 126 out of distal tip104. Needle assembly 124 is retracted until substantially proximal tovacuum chamber 108. The cycle is then repeated for a new portion ofstomach wall tissue using the same needle and the same suture withoutthe need for multiple intubations. Once the desired number of tissuemounds has been sutured, needle 126 is retracted out the proximal end oflocking sleeve 110 to allow removal of needle 126 from the suture. Thesuture is then threaded into a suture securing device as describedbelow. It is to be noted that the use of the same suture to securemultiple tissue folds allows for the determination of the distancebetween adjacent tissue folds. Suture 118 is typically provided on areel having graduations. By monitoring the length of suture beingadvanced off the reel from one tissue fold to the next, the operator canapproximate the distance of the tissue folds.

In an alternative embodiment, a suture tag 150 is used in conjunctionwith needle 126 to effectuate the suturing of multiple tissue moundswith one intubation. Depicted in FIG. 17, tag 150 is a generallycylindrical in overall shape with a through bore formed preferably alonga central longitudinal axis. Formed in a sidewall of tag 150 are notches152 that are preferably diametrically opposed to engage springs 142.Tags 150 are dimensioned to fit within a channel 129 formed in a needle126′ that is a modified version of needle 126 as shown in FIGS. 15A, 15Band 16. The dimensions of tag 152 are adjusted so that a sidewall of tag150 frictionally engages an inner wall of needle 126′ when lockingsleeve 110 is advanced distally over needle 120. The frictionalengagement is sufficient to allow for the transfer of tag 150 throughcapsule 102 with an attached suture 118 but weak enough to be overcomeby the radial engagement of springs 142 with detents 152 when lockingsleeve 110 is retracted. Needle 126′ has a slot 127′ that preferablyextends the entire length of needle 126′ to allow for the needlesidewall to expand radially outwardly to release tag 150. The featuresof needle 126′ that allow engagement with pusher 120 are not shown forpurposes of clarity but are the same as those for needle 126. In thisembodiment, however, locking sleeve 110 is retracted only from thedistal end of needle 126′ to allow for the release of tag 152 but notthe release of needle 126′ from pusher 120.

Operation of this embodiment is graphically illustrated in FIGS.18A-18I. To begin operation this embodiment, suture 118 is secured totag 150 via any number of conventional means as described above for theaffixation of suture 118 to needle 126. The combination of tag 150 andsuture 18 is then mounted in needle 126′. The needle/tag/suture assemblyis advanced through locking sleeve 110 via pusher 120 in the same manneras described for needle 126 and as shown in FIG. 18B. Following thesuction of a tissue fold into vacuum chamber 108, shown in FIG. 18A, theassembly is forced through tissue mound 95 and into distal tip 104 (FIG.18C). Springs 142 engage detents 152 upon delivery of tag 152 intodistal tip 104. Locking sleeve 110 is partially retracted from thedistal end of needle 126′ to allow for the release of tag 150. Needle126′ is retracted by proximally retracting pusher 120 in the mannerdescribed for needle 126 and as shown in FIG. 18D. The engaging surfacesof detents 152 and springs 142 overcome the frictional engagement of tag150 to needle 126′ and cause the sidewall of needle 126′ to flexradially outwardly to release tag 150 which is retained in distal tip104.

Upon retraction of needle 126′ substantially proximal to vacuum chamber108, suction is terminated to allow for the release of tissue mound 95with suture 118 secured therein as shown in FIG. 18E. Needle 126′ isthen distally advanced into distal tip 104 to re-engage tag 150 as shownin FIG. 18F. Sliding sleeve 110 is advanced to an extreme distalposition to allow for the capture of tag 150 within needle 126′. Thecombination of locking sleeve 110, needle 126′, tag 150 and pusher 120are retracted, preferably in unison by simultaneously retracting thepusher handle 122 and the locking sleeve handle to preferably retractthe combination proximal to vacuum chamber 108 as shown in FIG. 18G. Theprocess is then repeated with second tissue mound 95′ as shown in FIGS.18H and 18I. An alternate embodiment is shown in FIGS. 10A-10D in whichthe tag retaining features are eliminated in distal tip 104 and tags 150are used as anchors, one per tissue mound. In this alternate embodiment,needle assembly is completely removed from the device to allow foradditional tags 150 to be secured to the same suture. Once a desirednumber of tissue mounds have been sutured, the next step is to securethe suture and cinch the mounds together into a plication.

Referring to FIGS. 21, 23 and 24, the distal end of a suture clipdelivery and locking catheter is shown generally as 200. Catheter distalend 200 is comprised primarily of a collet cage 202 to which the othercomponents of distal end 200 are attached. Collet cage 202 isessentially a cylinder with two or more collet fingers 208 extendingdistally from a distal end of collet cage 202. When viewed from a distalend of collet cage 202, collet fingers 208 preferably form a segmented360° ring. Extending radially inwardly from a distal end of each colletfinger 208 is a collet finger flange 210 that functions as a stop toarrest distal advancement of a suture clip assembly loaded into colletcage 202. The combination of the distal end of collet cage 202, colletfingers 208 and distal flanges 210 define a cage within which thecomponents of a suture clip are releasably encapsulated for delivery toa sutured tissue site. The cage further functions to align the sutureclip components for assembly.

In a preferred embodiment, collet finger flanges 210 have radiused outerdistal edges 212 to minimize trauma to a patient and radiused innerdistal edges 214 to ease loading of suture clip components. In oneembodiment (not shown), outer distal edges 212 extend radially outwardlybeyond outer walls of collet finger 208 to function as a stop for anouter sliding sleeve 220 described below. Inner proximal faces of colletfinger flanges 210 are oriented to a longitudinal axis of the colletfingers so that a plane occupied by flange proximal surfaces 216 formsan angle from about 90° to about 135° and preferably either 135° or 90°with 90° being the most preferred to maximize the stopping function.

Finger slots 218 are formed between and defined by collet fingers 208and function as egress ports for sutures threaded through the componentsof a suture clip loaded into collet cage 202. Preferably, collet fingers208 are biased in an open position so that radial force need only beapplied to move the fingers from an open, suture clip loading/releasingposition to a closed, suture clip confining position. Alternatively,finger collets 208 can be biased in a closed position as described inPCT Application No. PCT/US01/07349, the contents of which areincorporated herein by reference.

Situated within a hollow chamber defined by the inner walls of colletcage 202 is clip pusher 230 that freely slides within collet cage 202.Pusher 230 is adapted to be proximally advanced into registry withsuture clip components to urge the components into engagement withsuture 118. Pusher 230 can be a solid rod or a hollow cylinder such as ahypotube.

Situated in coaxial relationship with and freely sliding about colletcage 202 is outer sliding sleeve 220 that performs at least twofunctions; providing a radially inwardly directed force against colletfingers 208 to maintain the fingers in a closed position during sutureclip delivery to a tissue site to minimize potential trauma that couldbe caused by open collet fingers and providing a means to sever the tailends of a suture that has been secured with a suture clip. When advanceddistally, sliding sleeve 220 encompasses collet fingers 208 andrestricts radial movement of the fingers regardless whether the fingersare biased in an open or closed position. In this position, slidingsleeve 220 prevents premature opening of the collet.

When proximally retracted, sliding sleeve 220 severs directly orcooperates with other components to sever suture material proximal to acinched suture clip. In one embodiment shown in FIGS. 21-24, a sutureslot 222 is formed in the sidewall of sliding sleeve 220 preferably inthe area occupied by a proximal end of collet cage 202 when slidingsleeve 230 is in its distal most position. As shown in FIGS. 23-25, acollet cage cutting edge 203 is formed in a proximal end of slidingsleeve 220 at or near the distal end of collet cage 202 and extendsradially outwardly toward sliding sleeve 220. As shown, a distal end 223of suture slot 222 engages suture 118 and carries it toward a distal endof the body of collet cage 202. When the distal end 223 of suture slot222 travels past cutting edge 203, suture 118 is pinched between thesurfaces of suture slot 223 and cutting edge 203 that causes the sutureto be severed as shown in FIG. 25.

At least one suture slot 223 is formed toward the distal end of slidingsleeve 30 to provide egress for excess suture material that typicallyextends beyond the orifice through which the catheter is inserted. It ispreferred that finger slots 218 and suture slots 223 are at leastpartially aligned to allow a path for excess suture material to exit thesuture clip delivery device. To accomplish alignment, an optionalignment slot (not shown) can be formed preferably near a proximal endof sliding sleeve 30. An alignment pin (not shown) is optionally affixedto collet cage 202 and dimensioned to freely slide within the alignmentslot. A version of this alignment feature is described and shown in PCTApplication No. PCT/US01/07349.

The suture clips used in delivery device 200 are in the preferred formof a ring 260 and a plug 262. As shown in FIGS. 23-25, ring 260 isdimensioned to fit within collet cage 202 such that the concentricity ofring 260 is maintained with respect to the longitudinal axis of colletcage 202. Plug 262 is preferably of a headless design as shown anddimensioned to frictionally engage an inner wall of ring 260. Plug 262is preferably formed with tapered ends to facilitate reception of suture118, to ease insertion into ring 260 and to prevent abrasion of suture118 between the ends of plug 262 and ring 260. Further details of sutureclip components that can be used with delivery device 200 are disclosedin PCT Application No. PCT/US01/07349.

As will be appreciated, the cross-sectional diameter of plug 262 issmaller than the cross-sectional diameter of the outer wall of ring 260.Because of this necessary discrepancy in the dimensions of the sutureclip components, accommodation is needed in collet cage 202 to ensurethe concentricity of plug 262 when advanced distally into ring 260. Oneapproach is to establish a reduced diameter portion in the proximal endof collet cage 202 to receive and maintain plug 262 in alignment withring 260. In an alternate embodiment, shown in FIGS. 23-25, a generallycylindrical bushing 205 is provided in the proximal end of collet cage202 to reduce the complexity of the geometry of the inner walls ofcollet cage 202. Bushing 205 is adapted to allow for the free axialmovement of plug 262 within collet cage 202.

The overall configuration of the suture clip delivery device is shown inFIGS. 26 and 27. A control handle 270 is attached to a proximal end of acollet cage tube 271 that may be in the form of a hypotube. A distal endof tube 271 is attached to the proximal end of collet cage 202. Tube 271has an inner diameter that is adapted to receive clip pusher 230 thatslides freely within tube 271. To operate the working features of thedelivery device, two control surfaces are provided for advancing andretracting the various sliding components. The first, clip pusher handle232, is attached to the proximal end of clip pusher 230. The second issliding sleeve handle 274 which is attached to a proximal end of asliding sleeve tube 276, the distal end of which comprises slidingsleeve 220. Sliding sleeve tube 276 may be in the form of a hypotubewith an inner diameter dimensioned to receive collet cage tube 271 thatslides freely within sliding sleeve tube 276. Clip pusher 230, colletcage tube 271 and sliding sleeve tube 276 are all coaxially arranged toallow the system to be dimensioned to slide freely within the workingchannel of endoscope 90 and the needle assembly channel of capsule 102.

To operate the suture clip delivery device, clip pusher handle 232 andsliding sleeve handle 274 are retracted to allow collet fingers 208 tospring radially outwardly to receive the suture clip components, plug262 and ring 260. Next, suture 118 previously placed into a plurality oftissue mounds is threaded through ring 260, collet cage 202 and outsuture slot 222. The ends of the suture are maintained out of thedelivery device and endoscope 90.

With the suture threaded through the suture clip delivery device, thedevice is distally advanced through the working channel of endoscope 90,into the proximal end of capsule 102 and into vacuum chamber 108 asshown in FIGS. 18J, 18K and 22. The device is now in a position to beginthe suture cinching procedure. Because of inherent flexibility in thedevice, collet cage 202 may slightly rotate out of axial alignment withthe longitudinal axis of capsule 102 toward the sutured tissue moundsvia the tension created by suture 118. This is a desired effect as itallows the distal end of collet cage 202 to come into closer proximityto the last tissue mound sutured. This maximizes the potential toprovide a tight plication since suture slack can be minimized. In short,the tissue mounds can be cinched closer together the closer collet cage202 can be situated to the tissue mounds.

The cinching process begins by providing a distally directed force ontoclip pusher handle 232. This causes the forward advancement of pusher230 into registration with the proximal end of plug 262 that, in turn,is urged distally into ring 260 to thereby capture suture 118 via thefrictional engagement of plug 262 to ring 260. Once plug 262 has beenpreferably fully engaged to ring 260, sliding sleeve handle 274 can beproximally retracted to sever the excess suture 118 and to allow colletfingers 208 to flex radially outwardly to allow for the release of thecinched suture clip as shown in FIG. 18L. The plication formed accordingto the procedure described herein forms a FIG. 8 suture pattern with anattached suture clip as shown in FIG. 13. FIGS. 11 and 14 show aplication formed with the use of tag 150 as an anchor with twists in thetissue mounds and suture paths shown with directional arrows. Thedelivery device can then be retracted out of capsule 102 and endoscope90 to end the procedure or to prepare for another cycle of suturing andsuture cinching. At all times during the procedure or multiple cycles ofthe procedures described herein, endoscope 90 and capsule 102 can bemaintained in the patient with a single intubation event. Endoscope issimply maneuvered to the desired tissue locations to perform thegastroplasty procedure.

It should be understood that the foregoing description of the inventionis intended merely to be illustrative thereof and that othermodifications, embodiments and equivalents may be apparent to those whoare skilled in the art without departing from its spirit.

1. A method of treating obesity, the method consisting of:endoscopically forming at least one plication in a stomach by performingacts of: (a) endoscopically suturing stomach tissue with at least onesuture using an endoscopic suturing device; and (b) endoscopicallysecuring the suture to the stomach tissue with an endoscopic suturesecuring device.
 2. The method according to claim 1, wherein act (a)includes collecting stomach tissue with the endoscopic suturing device,and sewing the collected stomach tissue with the suture.
 3. The methodaccording to claim 2, wherein the endoscopic suturing device includes acapsule adapted to collect tissue, and act (a) includes collectingstomach tissue with the capsule.
 4. The method according to claim 3,wherein the capsule includes a suction port, and act (a) includessuctioning stomach tissue into the capsule through the suction port. 5.The method according to claim 1, wherein the endoscopic suturing deviceincludes a needle with the suture being attached to the needle, and act(a) includes advancing the needle and the suture through the collectedstomach tissue.
 6. The method according to claim 5, wherein act (b)includes inserting the endoscopic securing device into the endoscopicsuturing device.
 7. The method according to claim 6, wherein act (b)includes removing the needle from the endoscopic suturing device andsubsequently inserting the endoscopic suture securing device into theendoscopic suturing device to secure the suture.
 8. The method accordingto claim 1, wherein act (b) includes securing the suture with a sutureclip delivered with the endoscopic securing device.
 9. The methodaccording to claim 8, wherein act (b) includes releasing the suture clipfrom the endoscopic securing device after securing the suture.
 10. Themethod according to claim 1, wherein acts (a) and (b) are both performedduring a single endoscopic intubation.
 11. A method of treating obesity,the method consisting of: endoscopically forming at least one plicationin a stomach by performing acts of: (a) endoscopically capturing stomachtissue; (b) endoscopically placing at least one suture in the capturedstomach tissue; and (c) endoscopically securing the suture to thestomach tissue.
 12. The method according to claim 11, wherein acts (a)and (b) are performed with an endoscopic suturing device.
 13. The methodaccording to claim 12, wherein the endoscopic suturing device includes acapsule having a suction port, and act (a) includes suctioning thestomach tissue into the capsule through the suction port.
 14. The methodaccording to claim 12, wherein act (c) is performed with an endoscopicsuture securing device.
 15. The method according to claim 14, whereinthe endoscopic suture securing device includes a suture clip, and act(c) includes securing the suture with the suture clip.
 16. The methodaccording to claim 14, wherein act (c) includes inserting the endoscopicsuture securing device into the endoscopic suturing device.
 17. Themethod according to claim 16, wherein the endoscopic suturing deviceincludes a needle with the suture attached to the needle, act (b)includes advancing the needle and the suture through the capturedtissue, and act (c) includes removing the needle from the endoscopicsuturing device before inserting the endoscopic suture securing deviceinto the endoscopic suturing device.
 18. The method according to claim11, wherein acts (a) to (c) are all performed during a single endoscopicintubation.